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Re: Bioburden determination

Chad,

I would like to clarify the following in your question.   Bioburden testing 
and Microbial limits test are two different tests.

The bioburden test is performed to determine the number of viable 
microorganism present in the article irrespective of the type of organism 
prior to processing; such as sterilization, filtration, etc, etc.

The Microbial limits is performed to screen for specific microorganisms in 
the article that may have harmful effect if consumed.   Therefore the 
article should be free of these specific organisms;  Pseudomonas 
aeruginaosa, Staphylococcus aureus, E.coli,  Salmonella species.

Now to answer your question;  If  you are testing microbial limits, it is 
always good to follow U.S.P. as precise as possible.   There will not be 
any questions.

If you are testing for bioburden limit and using the same criteria as 
microbial limits (<10cfu/ml or g), it does not matter what dilution you use 
as far as you express the results per g or ml of raw material.

Hope this helps.

Latha Chelvakumar
Quality Assurance Technical
Alpha Therapeutic Corporation
latha.chelvakumar@alphather.com



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